Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
7766
Study information
Scientific title
A pragmatic, prospective, randomised controlled trial comparing upper ministernotomy to full median sternotomy as a surgical approach for aortic valve replacement
Acronym
MiniStern Trial
Study hypothesis
MiniStern is a pragmatic, prospective randomised controlled trial comparing upper mini-sternotomy to full median sternotomy as a surgical approach to first time isolated aortic valve replacement (AVR).
Ethics approval
MREC approved (ref: 09/H0301/58)
Study design
Single-centre randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Topic: Cardiovascular, Generic Health Relevance and Cross Cutting Themes; Subtopic: Cardiovascular (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Cardiovascular, Surgery
Intervention
Comparing upper mini-sternotomy to full median sternotomy as a surgical approach to first time isolated aortic valve replacement (AVR).
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measures
Total length of stay in hospital for the index AVR operation measured in days
Secondary outcome measures
1. Fitness for discharge
2. Health related quality of life and patient satisfaction at baseline, 6 weeks, 6 months and 12 months using the 36-item short form health survey (SF-36) and Coronary Revascularization Outcome Questionnaire - Coronary Artery Bypass Graft (CROQ-CABG)
3. Heart function (LVEF) by echocardiography at baseline, day of discharge and 6 months post surgery
4. Procedure time: total theatre time, cross clamp time, cardiopulmonary bypass time, blood loss, blood transfusion
5. Respiratory function (forced expiratory volume in one second [FEV1]) by hand held spirometry at baseline, day 4, day of discharge, 6 weeks and 6 months
Overall trial start date
30/11/2009
Overall trial end date
01/09/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged greater than 18 years at the time of surgery, either sex
2. Elective, first time, isolated aortic valve replacement (AVR)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 240
Participant exclusion criteria
1. Documented poor left ventricular (LV) function or left ventricular ejection fraction (LVEF) 30%
2. Documented chest wall deformities
3. Documented severe emphysema or chronic obstructive pulmonary disease (COPD)
4. Current body mass index (BMI) greater than 35 kg/m^2
5. Concomitant cardiac surgery
6. Redo surgery
7. Median sternotomy indicated
Recruitment start date
30/11/2009
Recruitment end date
01/09/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Papworth Hospital NHS Foundation Trust
Cambridge
CB23 3RE
United Kingdom
Sponsor information
Organisation
Papworth Hospital NHS Foundation Trust (UK)
Sponsor details
Papworth Everard
Cambridge
CB3 8RE
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Central Commissioning Facility (CCF)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary